Novavax Reports Positive Results From Phase 1 Trial of its COVID-19 Vaccine Candidate

Novavax has announced preliminary data from a phase 1 trial of its COVID-19 vaccine NVX-CoV2373 in Australia that showed the vaccine generated a strong immune response.

The company began the phase 1/2 trial of the vaccine in May. The phase 1 portion in 131 healthy volunteers ages 18-59 years evaluated two 5mcg or 25mcg injections of the vaccine with or without an adjuvant compared with a placebo.

NVX-CoV2373 produced neutralizing antibodies in every participant after a single dose, the company said. Participants who received an adjuvanted vaccine also exhibited a T-cell response against the virus. The vaccine was well-tolerated, and adverse reactions were generally mild.

The company “couldn’t have asked for a better profile of a vaccine,” said Novavax CEO Stanley Erck, adding that the company got “all the immune responses that we could ask for” from a phase 1 trial.

Erck said the company has submitted the data to the FDA and is waiting for clearance to begin the phase 2 portion of the trial in the U.S. and Australia. It is also planning global efficacy trials, the first of which is slated to begin next month.

The company received a $1.6 billion contract from the U.S. government under Operation Warp Speed last month to produce 100 million doses of the vaccine for delivery next year (DID, July 8). Novavax tapped Fujifilm to help manufacture the vaccine for an upcoming phase 3 trial (DID, July 27). — Jordan Williams